Phase 3Active, not recruiting
A Study to Evaluate the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
A Randomized, Multicenter, Open-label, Phase III Study to Compare the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab, Fluoropyrimidine-based and Platinum-based Chemotherapy (Hereinafter Referred to as "Chemotherapy") Versus Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
- Sponsor
- Ono Pharmaceutical Co., Ltd. (Industry)
- Enrollment
- 626 enrolled
- Conditions
- Gastric Cancer
- Interventions
- ONO-4538; Ipilimumab; Oxaliplatin; Capecitabine; S-1
- Ages
- adults, older adults
- Registry
- NCT05144854
Full record on ClinicalTrials.gov
From the registry
This study is to compare and evaluate the efficacy and safety of ONO-4538 in combination with ipilimumab and chemotherapy versus chemotherapy in chemotherapy-naïve participants with HER2-negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).
Primary outcomes
- Overall survival (OS)
History
Study completion expected
Last registry update
Primary completion
Registered
Started